Procedure for Documentation of Equipment Validation

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for documenting equipment validation activities in ointment manufacturing. Proper documentation ensures compliance with regulatory requirements, traceability, and verification of validation processes.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, and Production departments responsible for executing, reviewing, and maintaining documentation for equipment validation.

3. Responsibilities

• QA Officer: Ensures accurate and complete validation documentation.
• Validation Team: Develops, executes, and maintains validation documents.
• Engineering Team: Provides equipment specifications and installation records.
• Production Supervisor: Records operational data for validation activities.
• QA Manager: Reviews and approves validation records and reports.

4. Accountability

The QA and Validation Managers are accountable for ensuring that equipment validation documentation complies with GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Types of Equipment Validation Documents

• Validation Master Plan (VMP)
• Installation Qualification (IQ) Protocol and Report
• Operational Qualification (OQ) Protocol and Report
• Performance Qualification (PQ) Protocol and Report
• Requalification Reports
• Deviation and CAPA (Corrective and Preventive Action) Reports

5.2 Documentation of Validation Activities

• Maintain structured records for each stage of validation.
• Ensure each record includes:
  • Equipment details (ID, model, manufacturer)
  • Test parameters